Pharmaceutical Sector Country Profile Questionnaire ETHIOPIA

Pharmaceutical Sector Country Profile Questionnaire ETHIOPIA The Pharmaceutical Sector Country Profile Survey 1. Background and Rationale: Pharmac...
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Pharmaceutical Sector Country Profile Questionnaire

ETHIOPIA

The Pharmaceutical Sector Country Profile Survey

1. Background and Rationale: Pharmaceutical Sector Country Profiles aim to increase the availability of quality information on structures, processes and outcomes of health and pharmaceutical sectors of countries. This information will be collected through a questionnaire and is meant to be used by country decision-makers, health and pharmaceutical experts, international partners and the public through databases and published country, regional and global reports. The information is categorized in nine sections, namely: (1) Health and Demographic data, (2) Health Services, (3) Medicines Policies, (4) Medicines Trade and Production, (5) Medicines Regulation, (6) Medicines Financing, (7) Pharmaceutical Procurement and distribution, (8) Selection and Rational Use and (9) Household data/access. Every four years since 1999, health officials from the 193 WHO Member States have been invited to complete a standardized questionnaire (named Level I) reporting on the status of the national pharmaceutical situation. Level I indicators assessed structures and processes related to the pharmaceutical situation of a country. They were used to carry out a rapid assessment that would highlight strengths and weaknesses of countries pharmaceutical situations. 156 countries responded to the 2007 level I survey and the results were stored and available in a global WHO database and used to develop a global report as well as a number of regional and sub-regional reports. The Pharmaceutical Sector Country Profile questionnaire described here will replace the Level I tool for the 2011 Member States' survey. The aim of this new approach is to build on the achievements and lessons learnt from the Level I tools and surveys and to improve the quality and scope of information (e.g, outcomes and results indicators) and enhance the involvement and ownership of countries in the development of profiles. The new tool has been piloted in the 15 countries of the Southern African Development Community in 2009 and in 13 countries across the world in 2010. The results

of

these

pilots

are

available

on-line

at:

http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index.html Another innovation of the 2011 survey is the collaboration between WHO and The Global Fund. In 2009, the Global Fund developed and introduced the Pharmaceutical and Health Product Management ("PHPM") Country Profile to gradually replace the Procurement and Supply Management ("PSM") Plan. In the course of 2010 both agencies have developed a joint Pharmaceutical Sector Country Profile questionnaire that includes key indicators of the Pharmaceutical Sector Country Profile Questionnaire. Final Version.

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pharmaceutical sector and that will be used by both agencies as the sole tool for pharmaceutical sector data collection in countries. The information captured in the Pharmaceutical Sector Country Profile questionnaire will be used by the Global Fund during grant negotiations and signing, and will also support grant implementation. In addition to the Country Profile that provides an overview of countries' pharmaceutical sectors, the Global Fund will also use a second questionnaire that will focus in more detail on medicines procurement and supply.

2. What can Pharmaceutical Sector Country Profiles offer: Completing this questionnaire will require the time of national experts and responsible officers but it is worthwhile as your country and your partners will benefit from it in a number of ways: I) The questionnaire offers a unique opportunity to consolidate, in one place, information that is available in different locations and institutions e.g. the National Medicines Regulatory Authority, Central Medical Stores, National Health Accounts, etc. II) The methodology proposed for filling in the questionnaire will ensure that good quality data are collected and that the source and date of information are known and reported. III) Data on structure, process and outcomes are collected, and the questionnaire has been pre-filled with data available in the public domain; indicators are divided into core and supplementary in order to make it easier to identify what is more important. IV) The data collected will highlight the strengths and weaknesses of the pharmaceutical sector and will be made available in a national database as official country information, for use by decision-makers, health and pharmaceutical experts, researchers and international partners and the public.. V) The data collected could be transformed into a narrative report with robust data analysis and bibliographic references, that will summarize the medicines situation in the country. VI) Based on experiences from previous surveys, a detailed glossary of key definitions and a manual for use of the questionnaire have been developed and can be found at the end of the questionnaire.

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3. The process of data collection and analysis: 3.1 Data collection. The Pharmaceutical Sector Country Profile questionnaire has already been filled in by WHO with reliable data available from global and country sources. We kindly ask you to review, to correct (if necessary) and to validate the information already included in the questionnaire, and also to fill in the gaps, based on reliable information available in your country. In order to do this, we recommend that you involve the most appropriate respondents and responsible institutions to fill in the various components of the tool so that the questionnaire is completed within the given deadline, with good quality information. If during the data collection process, clarifications are needed, WHO Regional and Headquarters Offices will provide the necessary assistance and support, including for data quality issues. 3.2 Official endorsement. Once the questionnaire has been completed, the information contained in it should be officially endorsed and its disclosure authorized by a senior official in the Ministry of Health. This should be done by signing the formal endorsement form attached to the questionnaire. This will ensure that the quality of the information contained in the Pharmaceutical Sector Country Profile questionnaire is certified by the country. 3.3 Data shared with the Global Fund. Data collected from Global Fund priority countries will be shared with the Global Fund and it will be used as part of the Global Fund's own grant signing and implementation procedures. 3.4 Data posted on key databases. Data endorsed by the country will be posted on health databases (such as the WHO

Global

Health

Observatory,

http://www.who.int/gho/en/), making it available to decision-makers, health and medicines experts and researchers, international partners and the public.

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3.5 Development of narrative Pharmaceutical Sector Country Profiles. Data provided within the country questionnaire can be used by the country to develop a narrative profile that will illustrate the national pharmaceutical sector. In order to do this, WHO has prepared a template profile (included in the CD-Rom shared with you) that can be easily used by countries and that will help presenting data in the form of tables, graphs and charts. Countries could seek support from WHO for the development of their narrative profile, which will be finalized and validated by the country that will own the copyright for it and will publish it as a national official document. 3.6 Development of Regional and Global Reports. The information provided by countries in the Pharmaceutical Sector Country Profile questionnaire will be analysed by WHO and used to produce regional and global reports on the pharmaceutical sector of countries in 2011. These reports will provide an overview of the progress made between 2007 and 2011, of the challenges that remain to be addressed and will include data analysis by technical areas, countries' income level and geographical location.

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Guidelines for countries on how to fill in the Pharmaceutical Sector Country Profile Questionnaire Please read these instructions carefully before starting data collection

1. Macros: the questionnaire has macros installed. A macro is a series of MS Word commands and instructions that are grouped together as a single command to accomplish a task automatically. For these macros to work properly, the macro security levels for MS Word on your computer should be set as 'low'. This can be easily adjusted by taking the following steps: 1. Open the Word document containing the instrument. 2. Go to 'Tools' > 'Macro' > 'Security'. 3. Click on the tab 'Security Level'. 4. Set the Security on 'Low' and click 'OK'. After filling in the questionnaire, the setting should be restored to a higher level of security in order to protect your computer. 2. Core and supplementary indicators: the instrument consists of core and supplementary questions. Core questions cover the most important information, while supplementary questions deal with more specific information applicable to particular sections. Please note that core questions have been shaded with different coloured backgrounds for different sections of the instrument, while supplementary questions are all white. This should help you to distinguish between the different categories of indicators. Please try to fill in all the core questions for each section before moving to the supplementary ones. Remember that we are only asking you to collect information that is already available and you are not expected to conduct any additional survey(s). 3. Prefilled data: the answers to some of the questions have been prefilled by WHO HQ. Where this is the case, please verify this information as it may not be up-to-date. If you find that any of the prefilled responses are not correct, please change the value and document the source and year.

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4. Calculated fields: for a few items, you will not be required to enter any value as these will be generated at WHO HQ using data entered into related fields. These fields have been clearly marked in red – please do not input any data into them or change data that are already in this field. For example, the per capita expenditure on health will be automatically calculated once the total health expenditure and population are entered into the questionnaire. This system is intended to improve the quality of answers and avoid you having to perform additional calculations. Calculated fields are protected and cannot be changed.

5. Possible answers: Checkbox 'Yes/No/Unknown': tick one of the three options (only one answer is possible). Multiple choice checkbox: tick any of the options that apply (multiple answers are sometimes possible). Percentage fields: 0-100. Please use decimal points ('dots') for decimals (example: 98.11). Please do not use ranges (e.g. "3-5"). If you only have ranges, then use the median and otherwise the mean. In this instance, please detail what data you have used and what the range is in the comment boxes. Number fields: unlimited number. Please use decimal points ('dots') for decimals (example: 29387.93). Please do not use ranges. If you only have ranges, then use the median and otherwise the mean. In this instance, please detail what data you have used and what the range is in the comment boxes. 6. Comments: comments fields allow the entry of free text to clarify or follow up on answers given. Please reference each comment by using the number of the question you are referring to (example: 2.01.02). 7. Year of data : year fields should be used to specify the year of the data used to answer the question. Only values between 1930 and 2011 will be accepted. Please use this column as follows: -

When the source refers directly to a specific document (for example: 'Medicines Act' or 'EML'), please put in the publication year of the document (note: only the year and not a specific date can be entered).

-

When the source refers to a document that contains older data than the document itself, please put in the original year of the data. For example, when the total population for 2008 is extracted from the World Health Statistics 2010, please put 2008 in the 'year' column and 'World Health Statistics 2010' in the 'source' column.

-

When the source of the information is not a document, but the informant himself/herself, please put in the current year.

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8. Source of data: sources used for the answers given will be referenced in the narrative country profile and in the databases in which the information will be stored. Please specify your sources as clearly as possible by providing the name, year, and writer/publisher of the documents used. Also provide a web (URL) link to the documents, if available. If there is only a non-English version of the reference available, then please include it regardless of the language. Use the 'source' column to enter the name and year of the source, and use the "Comments and References" fields at the end of every section to list the sources. In case the source is not documented, then provide the name and title of the person and/or the entity they work for as a source of information. Examples are given below.

9. Documents: you will see in the questionnaire that we would like you to collect and share a number of key country documents that we believe would greatly enrich the country’s profile content and these documents could be made available through countries and WHO web pages. Please attach the following documents, if available: -

National Medicines Policy (NMP);

-

NMP implementation plan;

-

National Medicines Act;

-

National pharmaceutical Human Resources report or strategic plan;

-

Latest report on the national pharmaceutical market (any source);

-

Pharmacovigilance national centre report (including an Adverse Drug Reaction (ADR), analysis report produced in the last two years);

-

National pharmaceutical legislation or regulation;

-

Annual report of quality control laboratories;

Pharmaceutical Sector Country Profile Questionnaire. Final Version.

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-

Annual report of national regulatory authority;

-

Legal provisions on medicines price regulations;

-

Medicines procurement policy;

-

National Essential Medicines List (EML);

-

National Standard Treatment Guidelines (STGs);

-

National strategy for antimicrobial resistance;

-

Any other medicines pricing/availability surveys, household surveys and rational use surveys, in addition to the ones used to prefill the instrument.

The last page of the questionnaire contains a table with the list of key documents to be attached. Please fill it in by indicating the exact title, publisher and year for each attachment as shown in the example below.

Document

Exact title

Author

Publisher

Year

File name

2009

EML.doc

2005

NDP.pdf

National

Ministry of

Ministry of

Medicines List

Health

Health

National Medicines

National Drug

Federal Ministry

Federal Ministry

Policy

Policy

of Health

of Health

Essential Medicines List

These documents will be published on the WHO web site's medicines library (http://apps.who.int/medicinedocs/en/ ) and will therefore have to be endorsed by the Ministry of Health prior to being made publicly available. You can send us these documents by e-mail as attachments or you can upload them into a protected web site. Please use the table at the end of the instrument to report the title, year and author of the documents attached. 10. Attaching files to the questionnaire: please place all files to be attached in a single folder on your computer. Name the documents as follows: .doc (example: EML.doc). Then compress (ZIP) the files and attach the compressed file with the completed instrument to the email. If the total file size of the compressed file exceeds 7 MB, you can upload the documents in a protected file server called MedNet, which is managed by WHO. The procedure for doing this is very simple and please contact Mr Enrico Cinnella in WHO HQ, Geneva, ([email protected]) to be granted access to MedNet and to receive instructions on how to upload files. You can also upload documents to the WHO Medicines Documentation server at http://hinfo.humaninfo.ro/medicinedocs/, though the documents will only appear on the Medicines Documentation site at the beginning of the following month. Pharmaceutical Sector Country Profile Questionnaire. Final Version.

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11. Manual for use of the questionnaire: the manual contains detailed instructions on the questionnaire, on where to find information and how to answer questions. Questions that may be particularly problematic are marked with the following icon:

12. Glossary: the glossary contains definitions for all key and/or problematic items in the instrument. It is highly recommended that you use the glossary, since exact definitions might differ between countries and institutions. The glossary is at the end of the file. When a question contains an item that is defined in the glossary, the terms will be marked in bold, underlined and written in blue font.

definition of "pharmaceutical technicians and assistants" is in the glossary

Instructions are available for this specific question

13. Respondents and acknowledgements: at the beginning of every section there are fields available to fill in details about the respondent for that particular section. It is also possible to enter the details of multiple respondents. At the end of the instrument please add a list of contributors who should be acknowledged. Provide their names and the main organization(s) they work for. 14. Endorsement of data: A formal endorsement needs to be signed by a senior official in the Ministry of Health before the completed questionnaire is sent back to WHO. The endorsement form is included in the pack of CD-ROM documents you have received from WHO. Please present the endorsement form to a senior official in the Ministry of Health for signature, and for obtaining permission to use and publish the data.

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15. Process of creating a country profile document: The data you will collect using this questionnaire can be used to develop a pharmaceutical sector country profile for the country. Examples of profiles are available on-line at http://www.who.int/medicines/areas/coordination/coordination_assessment/en/index1.html WHO has prepared a template profile (included in the CD) that can be easily used by countries and that will help presenting data in the form of tables, graphs and charts. Countries can use the generic template provided by WHO and add the information in the questionnaire. Below you can find an example of the template that shows how fields can be changed according to the specific responses provided by each country.

In each section of the questionnaire you will find some comment boxes that you can use to expand on the answer to one or more questions. The text of these comments can also be included in the profile in order to present the country situation in more detail. In the questionnaire you are also asked to indicate the source and date of each piece of information you provide; these should be used to develop bibliographic references for the profile. If you prefer, WHO can develop the narrative profile and the Organization will then share the document with the country, which will own/maintain the copyright for it and will be able to publish it as a national document.

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Section 0 General Info 0.01 Contact Info 0.01.01

Country (precoded)

Ethiopia-RV

0.01.02

Name coordinator

Dr. Ariaya Hymete

0.01.03

Address (Street, City)

Addis Ababa

0.01.04

Phone number

0911 33 50 99

0.01.05

Email address

[email protected]

0.01.06

Web address

0.01.07

Institution

Addis Ababa University

Pharmaceutical Sector Country Profile Questionnaire.

Section 1 Health and Demographic data 1.00 Respondent Information Section 1 1.00.01

Name of person responsible for filling out Survey section 1

1.00.02

Phone number

1.00.03

Email address

1.00.04

Other respondents for filling out this section

1.01 Demographic and Socioeconomic Indicators Core questions (click here for help) Year 1.01.01

Population, total (,000)

2010

Source

WHS

83,099

1.01.02

Population growth rate (Annual %)

2008 MOH

2.8

Ethiopia 1.01.03

Total Gross Domestic Product (GDP) (millions US$)

28,526.3

1.01.04

GDP growth (Annual %)

8.7

1.01.05C

GDP per capita (US$ current exchange rate)

343.28

1.01.06

Comments and References

2009

2008

2006

World Bank data World Bank data IMF

Supplementary questions (click here for help) Year 1.01.07S

Population < 15 years (% of total

44

Pharmaceutical Sector Country Profile Questionnaire.

2009

Source

WHS

population) 1.01.08S

Population > 60 years (% of total population)

2009 MOH

3

Ethiopia 1.01.09S

Urban population (% of total population)

2009

MOH Ethiopia

WHS

15

1.01.10S

Fertility rate, total (Births per woman)

5.3

2008

1.01.11S

Population living with less than $1.25/day (international PPP) (%)

39.04

2005 MOH

Ethiopia 1.01.12S

Population living below nationally defined poverty line (%)

1.01.13S

Income share held by lowest 20% of the population (% of national income)

1.01.14S

Adult literacy rate, 15+ years (% of relevant population)

1.01.15S

Comments and References

2000

World Bank data

2005

World Bank data

47

9.28

36

2008

WHS

1.02 Mortality and Causes of Death Core questions (click here for help) Year

Pharmaceutical Sector Country Profile Questionnaire. 14

Source

1.02.01

Life expectancy at birth for men (Years)

2009 MOH

53

Ethiopia 1.02.02

Life expectancy at birth for women (Years)

2009 MOH

55

Ethiopia 1.02.03

Infant mortality rate, between birth and age 1 (/1,000 live births)

69

2008

WHS

1.02.04

Under 5 mortality rate (/1,000 live births)

109

2008

WHS

1.02.05

Maternal mortality ratio (/100,000 live births)

2011 MOH

470

Ethiopia Yes

1.02.06

Please provide a list of top 10 diseases causing mortality

1.02.06.01

Disease 1

Pneumonia

1.02.06.02

Disease 2

Other or unspecified effects of external cases

1.02.06.03

Disease 3

Tuberculosis

1.02.06.04

Disease 4

Human immuno defficiency virus (HIV) disease

1.02.06.05

Disease 5

Anaemias

1.02.06.06

Disease 6

Other unspecified diseases of the circulatory system

1.02.06.07

Disease 7

Hypertension and related diseases

1.02.06.08

Disease 8

Malaria (Clinical without laboratory confirmation)

Pharmaceutical Sector Country Profile Questionnaire. 15

1.02.06.09

Disease 9

Malaria (confirmed with P. falciparum)

1.02.06.10

Disease 10

Road traffic injuries

1.02.07

Please provide a list of top 10 diseases causing morbidity

Yes

1.02.07.01

Disease 1

Malaria (clinical without laboratory confirmation)

1.02.07.02

Disease 2

Acute upper respiratory tract infections

1.02.07.03

Disease 3

Dyspepsia

1.02.07.04

Disease 4

Other unspecified infections and parasitic diseases

1.02.07.05

Disease 5

Pneumonia

1.02.07.06

Disease 6

Other or unspecified diseases of the respiratory system

1.02.07.07

Disease 7

Malaria (Confirmed with species other than P. falciparum)

1.02.07.08

Disease 8

Diarrhea with blood (dysentery)

1.02.07.09

Disease 9

Helmianthiasis

1.02.07.10

Disease 10

Diseases of musculoskeletal system and connective tissues

1.02.08

Comments and References

Health and health related indicators, FDRE, MOH 2001EC

Supplementary questions (click here for help) Year

Source

1.02.09S

Adult mortality rate for both sexes between 15 and 60 years (/1,000 population)

307

2008

WHS

1.02.10S

Neonatal mortality rate ( /1,000 live births)

39

2008

WHS

1.02.11S

Age-standardized mortality rate by non-communicable diseases (/100,000 population)

817

2008

WHS

1.02.12S

Age-standardized mortality rate by cardiovascular diseases (/100,000

2009

WHS

384

Pharmaceutical Sector Country Profile Questionnaire. 16

population) 1.02.13S

Age-standardized mortality rate by cancer ( /100,000 population)

1.02.14S

Mortality rate for HIV/AIDS (/100,000 population)

1.02.15S

Mortality rate for tuberculosis (/100,000 population)

64

2008

WHS

1.02.16S

Mortality rate for Malaria (/100,000 population)

51

2006

WHS

1.02.17S

Comments and References

142

2009

81

2007

Pharmaceutical Sector Country Profile Questionnaire. 17

WHS

WHS

Section 2 Health Services 2.00 Respondent Information Section 2 2.00.01

Name of person responsible for filling out this section of the instrument

2.00.02

Phone number

2.00.03

Email address

2.00.04

Other respondents for filling out this section

2.01 Health Expenditures Core questions (click here for help) Year

Source

2.01.01.01

Total annual expenditure on health (millions NCU)

8,450.44

2008

NHA data

2.01.01.02

Total annual expenditure on health (millions US$ average exchange rate)

880.25

2008

NHA data

2.01.02C

Total health expenditure as % of Gross Domestic Product

3.0

2.01.03.01C

Total annual expenditure on health per capita (NCU)

101.70

2.01.03.02C

Total annual expenditure on health per capita (US$ average exchange rate)

2.01.04.01

General government annual expenditure on health (millions NCU)

4,803.14

2008

NHA data

2.01.04.02

General government annual expenditure on health (millions US$ average exchange rate)

500.33

2008

NHA data

2.01.05

Government annual expenditure on health as percentage of total government budget (% of total government budget)

9.07

2008

NHA data

10.60

Pharmaceutical Sector Country Profile Questionnaire.

2.01.06C

Government annual expenditure on health as % of total expenditure on health (% of total expenditure on health)

56.84

2.01.07.01C

Annual per capita government expenditure on health (NCU)

57.8

2.01.07.02C

Annual per capita government expenditure on health (US$ average exchange rate)

6.02

2.01.08C

Private health expenditure as % of total health expenditure (% of total expenditure on health)

43.16

2.01.09

Population covered by a public health service or public health insurance or social health insurance, or other sickness funds of total population)

2.01.10

Population covered by private health insurance (% of total population)

2.01.11.01

Total pharmaceutical expenditure (millions NCU)

2,439.2

2006

FMOH

2.01.11.02

Total pharmaceutical expenditure (millions US$ current exchange rate)

289.7

2006

FMOH

2.01.12.01C

Total pharmaceutical expenditure per capita (NCU)

29.35

2.01.12.02C

Total pharmaceutical expenditure per capita (US$ current exchange rate)

3.49

2.01.13C

Pharmaceutical expenditure as a % of GDP (% of GDP)

1.01

2006

FMOH

2.01.14C

Pharmaceutical expenditure as a % of Health Expenditure (% of total health expenditure)

32.91

2.01.15.01

Total public expenditure on

232.62

2008

Pharmaceutical Sector Country Profile Questionnaire. 19

NHA data

pharmaceuticals (millions NCU) 2.01.15.02

Total public expenditure on pharmaceuticals (millions US$ current exchange rate)

27.6

2.01.16C

Share of public expenditure on pharmaceuticals as percentage of total expenditure on pharmaceuticals (%)

9.53

2.01.17.01C

Total public expenditure on pharmaceuticals per capita (NCU)

2.01.17.02C

Total public expenditure on pharmaceuticals per capita (US$ current exchange rate)

0.33

2.01.18.01

Total private expenditure on pharmaceuticals (millions NCU)

1,146.5

2006

FMOH

2.01.18.02

Total private expenditure on pharmaceuticals (millions US$ current exchange rate)

136.2

2006

FMOH

2.01.19

Comments and References

Drug financing in Ethiopia, FMOH, 2007

2.8

Supplementary questions (click for help) Year 2.01.20S

Social security expenditure as % of government expenditure on health (% of government expenditure on health)

2.01.21S

Market share of generic pharmaceuticals [branded and INN] by value (%)

2.01.22S

Annual growth rate of total pharmaceuticals market value (%)

2.01.23S

Annual growth rate of generic pharmaceuticals market value (%)

0.0

2008

Pharmaceutical Sector Country Profile Questionnaire. 20

Source

NHA data

2.01.24S

Private out-of-pocket expenditure as % of private health expenditure (% of private expenditure on health)

80.49

2008

NHA data

2.01.25S

Premiums for private prepaid health plans as % of total private health expenditure (% of private expenditure on health)

3.02

2008

NHA data

2.01.26S

Comments and References

2.02 Health Personnel and Infrastructure Core questions (click for help) Year 2.02.01

Total number of pharmacists licensed/registered to practice in your country

Source

2009 Health

492

indicator MOH 2.02.02C

Pharmacists per 10,000 population

2.02.03

Total number of pharmacists working in the public sector

2.02.04

Total number of pharmaceutical technicians and assistants

2.02.05

A strategic plan for pharmaceutical human resource development is in place in your country?

2.02.06

Total number of physicians

0.06

1,023

Yes

2007

Global Health Atlas

No

2009 Health

2,151

indicator MOH 2.02.07C

Physicians per 10,000 pop

Pharmaceutical Sector Country Profile Questionnaire. 21

0.26 2.02.08

Total number of nursing and midwifery personnel

2009 Health

20,109

indicator MOH 2.02.09C

Nurses and midwives per 10,000 pop

2.42

2.02.10

Total number of hospitals

195

2.02.11

Number of hospital beds per 10,000 pop

2.00

2.02.12

Total number of primary health care units and centers

13850

2.02.13

Total number of licensed pharmacies

2.02.14

Comments and References

2008

2009

2009

Health indicator MOH World Health Survey 2010 Health indicator MOH

Health and health related indicators, FDRE, MOH 2001EC

Supplementary questions (click here for help) Year

Source

2.02.15S

Starting annual salary for a newly registered pharmacist in the public sector (NCU)

2807

2010

MOH

2.02.16S

Total number of pharmacists who graduated (first degree) in the past 2 years in your country

226

2007

rad.aid.org

2.02.17S

Are there accreditation requirements for pharmacy schools?

Yes

No

2010

SOP

2.02.18S

Is the Pharmacy Curriculum regularly reviewed?

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 22

2.02.19S

Comments and References

www.rad.aid.org

Pharmaceutical Sector Country Profile Questionnaire. 23

Section 3 Policy issues 3.00 Respondent Information Section 4 3.00.01

Name of person responsible for filling out this section of the instrument

3.00.02

Phone number

3.00.03

Email address

3.00.04

Other respondents for filling out this section

3.01 Policy Framework Core questions (click here for help) Year

Source

3.01.01

National Health Policy exists. If yes, please write year of the most recent document in the "year" field.

Yes

No

1993

Health policy MOH

3.01.02

National Health Policy Implementation plan exists. If yes, please write the year of the most recent document in the "year"

Yes

No

1995

Health sector strategy MOH

3.01.03

Please provide comments on the Health policy and its implementation plan

The health policy was put forward in 1993 and its implementation is in progress and achievements are there as indicated in the HSDP III MTR

3.01.04

National Medicines Policy official document exists. If yes, please write the year of the most recent document in the "year" field.

Yes

No

2007

WHO level I

3.01.05

Group of policies addressing pharmaceuticals exist.

Yes

No

1993

Health policy MOH

3.01.06

National Medicines Policy covers the following components:

Yes

Pharmaceutical Sector Country Profile Questionnaire.

3.01.06.01

Selection of Essential Medicines

Yes

3.01.06.02

Medicines Financing

Yes

3.01.06.03

Medicines Pricing

Yes

3.01.06.04

Medicines Procurement

Yes

3.01.06.05

Medicines Distribution

Yes

3.01.06.06

Medicines Regulation

Yes

3.01.06.07

Pharmacovigilance

Yes

3.01.06.08

Rational Use of Medicines

Yes

3.01.06.09

Human Resource Development

Yes

3.01.06.10

Research

Yes

3.01.06.11

Monitoring and Evaluation

Yes

3.01.06.12

Traditional Medicine

Yes

3.01.07

National medicines policy implementation plan exists. If yes, please write year of the most recent document.

Yes

3.01.08

Policy or group of policies on clinical laboratories exist. If yes, please write year of the most recent document in the "year" field

Yes

No

3.01.09

National clinical laboratory policy implementation plan exists. If yes, please write year of the most recent document in the "year" field

Yes

No

3.01.10

Access to essential medicines/technologies as part of the fulfillment of the right to health, recognized in the constitution or national legislation?

Yes

No

No

Pharmaceutical Sector Country Profile Questionnaire. 25

2007

WHO level I

Health policy MOH

3.01.11

There are official written guidelines on medicines donations.

Yes

3.01.12

Is pharmaceutical policy implementation being regularly monitored/assessed?

Yes

3.01.12.01

Who is responsible for pharmaceutical policy monitoring?

Food, Medicines and Health Care Administration and control Authority of ethiopia

3.01.13

Is there a national good governance policy?

Yes

3.01.13.01

Multisectoral

Yes

3.01.13.02

For the pharmaceutical sector

Yes

3.01.13.03

Which agencies are responsible?

3.01.14

A policy is in place to manage and sanction conflict of interest issues in pharmaceutical affairs.

Yes

No

3.01.15

There is a formal code of conduct for public officials.

Yes

No

3.01.16

Is there a whistle-blowing mechanism allowing individuals to raise a concern about wrongdoing occurring in the pharmaceutical sector of your country (ombudsperson)?

Yes

No

3.01.16.01

Please describe:

3.01.17

Comments and References

No

2007

WHO level I

No

No

http://cnhde.ei.columbia.edu http://collections.infocollections.org

Pharmaceutical Sector Country Profile Questionnaire. 26

Section 4 Medicines Trade and Production 4.00 Respondent Information Section 4 4.00.01

Name of person responsible for filling out this section of the instrument

Mr. Abdrazak Omer

4.00.02

Phone number

0911 500813

4.00.03

Email address

[email protected]

4.00.04

Other respondents for filling out this section

4.01 Intellectual Property Laws and Medicines Core questions (click here for help) Year 4.01.01

Country is a member of the World Trade Organization

4.01.02

Legal provisions provide for granting of Patents on:

Yes

No

WTO

2007

WHO level I

2007

WHO level I

Yes

4.01.02.01

Pharmaceuticals

Yes

No

4.01.02.02

Laboratory supplies

Yes

No

4.01.02.03

Medical supplies

Yes

No

4.01.02.04

Medical equipment

Yes

No

4.01.03.01

Please provide name and address of the institution responsible for managing and enforcing intellectual property rights

Ethiopian Intelectual Property Office

4.01.03.02

Please provide URL

http://www.eipo.gov.et

4.01.04

National Legislation has been modified to implement the TRIPS Agreement

Yes

No

4.01.05

Current laws contain (TRIPS)

Yes

No

Source

P.O.Box 25322 Addis Ababa, Ethiopia

Pharmaceutical Sector Country Profile Questionnaire.

2010

flexibilities and safeguards 4.01.06

Country is eligible for the transitional period to 2016

4.01.07

Which of the following (TRIPS) flexibilities and safeguards are present in the national law?

Yes

No

2007 Yes

4.01.07.01

Compulsory licensing provisions that can be applied for reasons of public health

Yes

No

4.01.07.02

Bolar exception

Yes

No

4.01.08

Are parallel importing provisions present in the national law?

Yes

No

4.01.09

The country is engaged in initiatives to strengthen capacity to manage and apply intellectual property rights to contribute to innovation and promote public health

Yes

No

4.01.10

Are there legal provisions for data exclusivity for pharmaceuticals

Yes

No

4.01.11

Legal provisions exist for patent extension

Yes

No

4.01.12

Legal provisions exist for linkage between patent status and Marketing Authorization

Yes

No

4.01.13

Comments and References

WHO level I

2007

WHO level I

Year

Source

4.01.04 Country not a member of the WTO

4.02 Manufacturing Core questions (click here for help)

4.02.01

Number of licensed pharmaceutical manufacturers in the country

4.02.02

Country has manufacturing capacity

13

2004

2007 Yes

Pharmaceutical Sector Country Profile Questionnaire. 28

DACA

WHO level I

4.02.02.01

R&D to discover new active substances

Yes

No

Unknown

4.02.02.02

Production of pharmaceutical starting materials (APIs)

Yes

No

Unknown

4.02.02.03

Production of formulations from pharmaceutical starting material

Yes

No

Unknown

4.02.02.04

Repackaging of finished dosage forms

Yes

No

Unknown

4.02.03

Percentage of market share by value produced by domestic manufacturers (%)

4.02.04

Comments and References

http://www.daca.gov.et/statisticsnew.html

Supplementary questions (click here for help) Year 4.02.05S

Percentage of market share by volume produced by domestic manufacturers (%)

4.02.06S

Number of multinational pharmaceutical companies manufacturing medicines locally

4.02.07S

Number of manufacturers that are Good Manufacturing Practice (GMP) certified

4.02.08S

Comments and References

Pharmaceutical Sector Country Profile Questionnaire. 29

Source

Section 5 Medicines Regulation 5.00 Respondent Information Section 4 5.00.01

Name of person responsible for filling out this section of the instrument

5.00.02

Phone number

5.00.03

Email address

5.00.04

Other respondents for filling out this section

5.01 Regulatory Framework Core questions (click here for help) Year

Source

5.01.01

Are there legal provisions establishing the powers and responsibilities of the Medicines Regulatory Authority (MRA)?

Yes

No

2007

WHO level I

5.01.02

There is a Medicines Regulatory Authority

Yes

No

2007

WHO level I

5.01.03

If yes, please provide name and address of the Medicines regulatory authority

Food, medicine and health care administration and control of Ethiopia (FMHACA)

5.01.04

The Medicines Regulatory Authority is:

Yes

5.01.04.01

Part of MoH

Yes

5.01.04.02

Semi autonomous agency

Yes

5.01.04.03

Other (please specify)

5.01.05

What are the functions of the National Medicines Regulatory Authority?

Parastatal agency

Yes

Pharmaceutical Sector Country Profile Questionnaire. 30

5.01.05.01

Marketing authorization / registration

Yes

No

5.01.05.02

Inspection

Yes

No

5.01.05.03

Import control

Yes

No

5.01.05.04

Licensing

Yes

No

5.01.05.05

Market control

Yes

No

5.01.05.06

Quality control

Yes

No

5.01.05.07

Medicines advertising and promotion

Yes

No

5.01.05.08

Clinical trials control

Yes

No

5.01.05.09

Pharmacovigilance

Yes

No

5.01.05.10

Other: (please explain)

Also controls veterinary drugs and traditional herbal medicines

5.01.06

Number of the MRA permanent staff

2009

Health indicator MOH

5.01.06.01

Date of response

5.01.07

The MRA has its own website

5.01.07.01

- If yes, please provide MRA site address (URL)

5.01.08

The MRA receives external technical assistance

5.01.08.01

If yes, please describe:

5.01.09

The MRA is involved in harmonization/ collaboration initiatives

5.01.09.01

- If yes, please specify

5.01.10

An assessment of the medicines regulatory system has been conducted in the last five years.

Yes Web

No

2009

WHO

http://www.daca.gov.et/

Yes

No

Yes

No

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 31

2007

WHO level I

5.01.11

Medicines Regulatory Authority gets funds from regular budget of the government.

Yes

No

2010

WHS

5.01.12

Medicines Regulatory Authority is funded from fees for services provided.

Yes

No

2007

WHO level 1

5.01.13

Medicines Regulatory Authority receives funds/support from other sources

Yes

No

2007

WHO level 1

5.01.13.01

- If yes, please specify

5.01.14

Revenues derived from regulatory activities are kept with the Regulatory

Yes

No

2010

WHS

Yes

No

Year

Source

Authority 5.01.15

The Regulatory Authority is using a computerized information management system to store and retrieve information on registration, inspections, etc.

5.01.16

Comments and References

5.02 Marketing Authorization (Registration) Core questions (click here for help)

5.02.01

Legal provisions require a Marketing Authorization (registration) for all pharmaceutical products on the market

Yes

No

2007

WHO level I

5.02.02

Are there any mechanism for exception/waiver of registration?

Yes

No

2010

Procl. 661/2009 FDRE

5.02.03

Are there mechanisms for recognition of registration done by other

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 32

countries 5.02.03.01

If yes, please explain:

5.02.04

Explicit and publicly available criteria exist for assessing applications for Marketing Authorization of pharmaceutical products

Yes

No

5.02.05

Information from the prequalification programme managed by WHO is used for product registration

Yes

No

5.02.06

Number of pharmaceutical products registered in your country

5.02.07

Legal provisions require the MRA to make the list of registered pharmaceuticals with defined periodicity publicly available

5.02.07.01

If yes, how frequently updated

5.02.07.02

If yes, please provide updated list or URL *

5.02.08

5.02.09

5.02.10

2010 4000

DACA

Yes

No

2007

WHO level I

Medicines registration always includes the INN (International Nonproprietary Names)

Yes

No

2007

WHO level I

Legal provisions require the payment of a fee for Medicines Marketing Authorization (registration) applications

Yes

No

2007

FMOH/

Comments and References

http://www.daca.gov.et/statisticsnew.html

WHO

Survey on prices of medicines in Ethiopia, FMOH/WHO, 2007 Guidelines for registration of human drugs, DACA

Supplementary questions (click here for help) Year

Pharmaceutical Sector Country Profile Questionnaire. 33

Source

5.02.11S

Legal provisions require Marketing Authorization holders to provide information about variations to the existing Marketing Authorization

Yes

No

5.02.12S

Legal provisions require publication of a Summary of Product Characteristics (SPCs) of the medicines registered

Yes

No

5.02.13S

Legal provisions require the establishment of an expert committee involved in the marketing authorization process

Yes

No

2007

WHO level I

5.02.14S

Certificate for Pharmaceutical Products in accordance with the WHO Certification scheme is required as part of the Marketing Authorization application

Yes

No

2007

WHO level I

5.02.15S

Legal provisions require declaration of potential conflict of interests for the experts involved in the assessment and decision-making for registration

Yes

No

5.02.16S

Legal provisions allow applicants to appeal against MRAs decisions

Yes

No

2010

Procl. 661/2009

DACA

FDRE 5.02.17S

Registration fee - the amount per application for pharmaceutical product containing New Chemical Entity (NCE) (US$)

5.02.18S

Registration fee - the Amount per application for a generic pharmaceutical product (US$)

5.02.19S

Time limit for the assessment of a Marketing Authorization application (months)

1

5.02.20S

Comments & References

Guidelines for registration of human drugs, DACA

DACA

Pharmaceutical Sector Country Profile Questionnaire. 34

5.03 Regulatory Inspection Core Questions(click here for help)

5.03.01

Legal provisions exist allowing for appointment of government pharmaceutical inspectors

Yes

No

Year

Source

2010

Procl. 661/2009 FDRE

5.03.02

Legal provisions exist permitting inspectors to inspect premises where pharmaceutical activities are performed

Yes

No

2010 Procl.

661/2009 FDRE 5.03.02.01

If yes, legal provisions exist requiring inspections to be performed

5.03.03

Inspection is a pre-requisite for licensing of:

Yes

No

2010 Yes

Procl. 661/2009 FDRE

5.03.03.01

Public facilities

Yes

No

5.03.03.02

Private facilities

Yes

No

5.03.04

Inspection requirements are the same for public and private facilities

Yes

No

5.03.05.01

Local manufactures are inspected for GMP compliance

Yes

No

2010 Proc.

661/2009 5.03.05.02

Private wholesalers are inspected

Yes

No

5.03.05.03

Retail distributors are inspected

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 35

5.03.05.04

Public pharmacies and stores are inspected

Yes

No

5.03.05.05

Pharmacies and dispensing points of health facilities are inspected

Yes

No

5.03.05.06

Please provide details on frequency of inspections for the different categories of facilities

Done at least once in a year and can be done when deemed necessary during the working hours.

5.03.06

Comments and References

Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.

5.04 Import Control Core Questions (click here for help)

5.04.01

Legal provisions exist requiring authorization to import medicines

Yes

No

Year

Source

2010

Procl. 661/2009 FDRE

5.04.02

Legal provisions exist allowing the sampling of imported products for testing

Yes

No

2010

Procl. 661/2009 FDRE

5.04.03

Legal provisions exist requiring importation of medicines through authorized ports of entry

Yes

No

2010

Procl. 661/2009 FDRE

5.04.04

5.04.05

Legal provisions exist allowing inspection of imported pharmaceutical products at the authorized ports of entry

Yes

No

2010

Procl. 661/2009

Comments and References

Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.

FDRE

5.05 Licensing

5.05.01

Legal provisions exist requiring

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 36

Year

Source

2007

WHO

manufacturers to be licensed 5.05.02

Legal provisions exist requiring both domestic and international manufacturers to comply with Good manufacturing Practices (GMP)

5.05.02.01

If no, please explain

5.05.03

level I Yes

No

DACA

GMP requirements are published by the government.

Yes

No

5.05.04

Legal provisions exist requiring importers to be licensed

Yes

No

2007

WHO level I

5.05.05

Legal provisions exist requiring wholesalers and distributors to be licensed

Yes

No

2007

WHO level I

5.05.06

Legal provisions exist requiring wholesalers and distributors to comply with Good Distributing Practices

Yes

No

2010

Procl. 661/2009

When filling in this part, please also fill in the relevant questions in the procurement and distribution section (Section 7) 5.05.07

National Good Distribution Practice requirements are published by the government

Yes

No

5.05.08

Legal provisions exist requiring pharmacists to be registered

Yes

No

FDRE 5.05.09

Legal provisions exists requiring private pharmacies to be licensed

Yes

No

2010

Procl. 661/2009 FDRE

5.05.10

Legal provision exist requiring public pharmacies to be licensed

Yes

No

2010

Procl. 661/2009 FDRE

Pharmaceutical Sector Country Profile Questionnaire. 37

5.05.11

National Good Pharmacy Practice Guidelines are published by the government

Yes

No

5.05.12

Legal provisions require the publication of a list of all licensed pharmaceutical facilities

Yes

No

5.05.13

Comments and References

Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.

5.06 Market Control and Quality Control Core Questions (click here for help)

5.06.01

Legal Provisions for regulating the pharmaceutical market exist

Yes

No

5.06.02

Does a laboratory exist in the country for Quality Control testing?

Yes

No

Year

Source

2010

Procl. 661/2009 FDRE

5.06.02.01

If yes, is the laboratory part of the MRA?

Yes

No

5.06.02.02

Does the regulatory authority contract services elsewhere?

Yes

No

5.06.02.03

If yes, please describe

5.06.03

Is there any national laboratory accepted for collaboration with WHO prequalification Programme? Please describe.

5.06.04

Medicines are tested:

2010

Procl. 661/2009

s FDRE 5.06.04.01

For quality monitoring in the public sector (routine sampling in pharmacy stores and health facilities)

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 38

5.06.04.02

For quality monitoring in private sector (routine sampling in retail outlets)

Yes

No

5.06.04.03

When there are complaints or problem reports

Yes

No

5.06.04.04

For product registration

Yes

No

5.06.04.05

For public procurement prequalification

Yes

No

5.06.04.06

For public program products prior to acceptance and/or distribution

Yes

No

5.06.05

Samples are collected by government inspectors for undertaking post-marketing surveillance testing

Yes

No

5.06.06

How many Quality Control samples were taken for testing in the last two years?

5.06.07

Total number of samples tested in the last two years that failed to meet quality standards

5.06.08

Results of quality testing in past two years are publicly available

Yes

No

5.06.09

Comments and References

Proclamation number 661/2009 of the Federal Democratic Republic of Ethiopia.

2007

WHO level I

5.07 Medicines Advertising and Promotion Core Questions (click here for help) Year

Source

2007

WHO level I

5.07.01

Legal provisions exist to control the promotion and/or advertising of prescription medicines

Yes

5.07.02

Who is responsible for regulating, promotion and/or advertising of

Food, Medicine and Health Care Administration of Ethiopia

No

Pharmaceutical Sector Country Profile Questionnaire. 39

medicines? Please describe: 5.07.03

Legal provisions prohibit direct advertising of prescription medicines to the public

Yes

No

2007

WHO level I

5.07.04

Legal provisions require a preapproval for medicines advertisements and promotional materials

Yes

No

2007

WHO level I

5.07.05

Guidelines/Regulations exist for advertising and promotion of nonprescription medicines

Yes

No

2007

WHO level I

5.07.06

A national code of conduct exists concerning advertising and promotion of medicines by marketing authorization holders and is publicly available

Yes

No

5.07.06.01

If yes, the code of conduct applies to domestic manufacturers only, multinational manufacturers only, or both

Yes

No

Domestic only

Yes

Multinational only

Yes

Both

Yes

5.07.06.02

If yes, adherence to the code is voluntary

Yes

No

5.07.06.03

If yes, the code contains a formal process for complaints and sanctions

Yes

No

5.07.06.04

If yes, list of complaints and sanctions for the last two years is publicly available

Yes

No

5.07.07

Comments and References

Guidelines on the requirements for the registration of pharmaceutical manufacturers

Pharmaceutical Sector Country Profile Questionnaire. 40

DACA

5.08 Clinical trials Core Questions (click here for help)

5.08.01

Legal provisions exist requiring authorization for conducting Clinical Trials by the MRA

Yes

No

Year

Source

2010

Procl. 661/2009 FDRE

5.08.02

Legal provisions exist requiring the agreement by an ethics committee/ institutional review board of the Clinical Trials to be performed

Yes

No

DACA

5.08.03

Legal provisions exist requiring registration of the clinical trials into international/national/regional registry

Yes

No

DACA

5.08.04

Comments and References

Guidelines for conducting clinical trials in Ethiopia

Supplementary questions (click here for help) Year

Source

5.08.05S

Legal provisions exist for GMP compliance of investigational products

Yes

No

DACA

5.08.06S

Legal provisions require sponsor, investigator to comply with Good Clinical Practices (GCP)

Yes

No

DACA

5.08.07S

National GCP regulations are published by the Government.

Yes

No

5.08.08S

Legal provisions permit inspection of facilities where clinical trials are performed

Yes

No

5.08.09S

Comments and References

Guidelines for conducting clinical trials in Ethiopia

5.09 Controlled Medicines

Pharmaceutical Sector Country Profile Questionnaire. 41

DACA

Core Questions (click here for help) Date 5.09.01

The country has adopted the following conventions:

Source

Yes

5.09.01.01

Single Convention on Narcotic Drugs, 1961

Yes

No

1965

Internatio nal Narcotics Control Board, 2010

5.09.01.02

The 1972 Protocol amending the Single Convention on Narcotic Drugs, 1961

Yes

No

1994

Internation al Narcotics Control Board, 2010

5.09.01.03

Convention on Psychotropic Substances 1971

Yes

No

1980

Internation al Narcotics Control Board, 2010

5.09.01.04

United Nations Convention against the Illicit Traffic in Narcotic Drugs and Psychotropic Substances, 1988

Yes

No

1990

Internation al Narcotics Control Board, 2010

5.09.02

Laws for the control of narcotic and psychotropic substances, and precursors exist

Yes

No

2010

Procl. 661/2009 FDRE

5.09.03

Annual consumption of Morphine (mg/capita)

5.09.04

Comments and References

0.000285

2009

Internation al Narcotics Control Board, 2010

Supplementary questions (click here for help) Year

Pharmaceutical Sector Country Profile Questionnaire. 42

Source

5.09.05S

The legal provisions and regulations for the control of narcotic and psychotropic substances, and precursors have been reviewed by a WHO International Expert or Partner Organization to assess the balance between the prevention of abuse and access for medical need

5.09.05.01S

If yes, year of review

5.09.06S

Annual consumption of Fentanyl (mg/capita)

5.09.07S

Annual consumption of Pethidine (mg/capita)

5.09.08S

Annual consumption of Oxycodone (mg/capita)

5.09.09S

Annual consumption of Hydrocodone (mg/capita)

5.09.10S

Annual consumption of Phenobarbital (mg/capita)

5.09.11S

Annual consumption of Methadone (mg/capita)

5.09.12S

Comments and References

Yes

No

0.161312

Unknown

2009

Internation al Narcotics Control Board, 2010

5.10 Pharmacovigilance Core Questions (click here for help)

5.10.01

There are legal provision in the Medicines Act that provides for pharmacovigilance activities as part of the MRA mandate

Yes

No

5.10.02

Legal provisions exist requiring the Marketing Authorization holder to

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 43

Year

Source

1993

Drug policy, FMOH

continuously monitor the safety of their products and report to the MRA 5.10.03

Legal provisions about monitoring Adverse Drug Reactions (ADR) exist in your country

Yes

No

DACA

5.10.04

A national pharmacovigilance centre linked to the MRA exists in your country

Yes

No

DACA

5.10.04.01

If a national pharmacovigilance centre exists in your country, how many staff does it employ fulltime

5.10.04.02

If a national pharmacovigilance center exists in your country, an analysis report has been published in the last two years.

Yes

No

5.10.04.03

If a national pharmacovigilance center exists in your country, it publishes an ADR bulletin

Yes

No

5.10.05

An official standardized form for reporting ADRs is used in your country

Yes

No

5.10.06

A national Adverse Drug Reactions database exists in your country

Yes

No

5.10.07

How many ADR reports are in the database?

5.10.08

How many reports have been submitted in the last two years?

5.10.09

Are ADR reports sent to the WHO database in Uppsala?

Yes

No

5.10.09.01

If yes, number of reports sent in the last two years

5.10.10

Is there a national ADR or pharmacovigilance advisory

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 44

DACA

DACA

committee able to provide technical assistance on causality assessment, risk assessment, risk management, case investigation and, where necessary, crisis management including crisis communication? 5.10.11

Is there a clear communication strategy for routine communication and crises communication?

Yes

No

5.10.12

In the absence of a national pharmacovigilance system, ADRs are monitored in at least one public health program (for example TB, HIV, AIDS)?

Yes

No

5.10.13

Please describe how you intend to enhance the Pharmacovigilance system

5.10.14

Comments and References

ADRmonitoring and promotion control division, DACA Is responsible to control the activity. Guidelines for Adverse Drug Reaction reporting, DACA

Supplementary questions (click here for help) Year 5.10.15S

Feedback is provided to reporters

Yes

No

5.10.16S

The ADR database is computerized

Yes

No

5.10.17S

Medication errors (MEs) are reported

Yes

No

5.10.18S

How many MEs are there in the ADRs database?

5.10.19S

There is a risk management plan presented as part of product dossier submitted for Marketing Authorization?

Yes

No

5.10.20S

In the past two years, who has reported ADRs?

Yes

Pharmaceutical Sector Country Profile Questionnaire. 45

Source

5.10.20.01S

Doctors

Yes

5.10.20.02S

Nurses

Yes

5.10.20.03S

Pharmacists

Yes

5.10.20.04S

Consumers

Yes

5.10.20.05S

Pharmaceutical Companies

Yes

5.10.20.06S

Others, please specify whom

5.10.21S

Was there any regulatory decision based on local pharmacovigilance data in the last 2 years?

Yes

No

5.10.22S

Are there training courses in pharmacovigilance?

Yes

No

5.10.22.01S

If yes, how many people have been trained in the last two years?

5.10.23S

Comments and References

Trainings on pharmacovigilance has been organized by DACA, EPA and others but there is on document indicating the number of trained professionals.

Pharmaceutical Sector Country Profile Questionnaire. 46

Section 6 Medicines Financing 6.00 Respondent Information Section 5 6.00.01

Name of person responsible for filling out this section of the instrument

6.00.02

Phone number

6.00.03

Email address

6.00.04

Other respondents for this sections

w/o Senait Seyoum Tel. 0911448790

6.01 Medicines Coverage and Exemptions Core Questions (click here for help) Year 6.01.01

Do the followings receive medicines free of charge:

Yes

6.01.01.01

Patients who cannot afford them

Yes

No

6.01.01.02

Children under 5

Yes

No

6.01.01.03

Pregnant women

Yes

No

6.01.01.04

Elderly persons

Yes

No

6.01.01.05

Please describe/explain your yes answers for questions above

6.01.02

Is there a public health system or social health insurance scheme or public programme providing medicines free of charge for :

Yes

6.01.02.01

All medicines included in the EML

Yes

No

6.01.02.02

Any non-communicable diseases

Yes

No

6.01.02.03

Malaria medicines

Yes

No

6.01.02.04

Tuberculosis medicines

Yes

No

6.01.02.05

Sexually transmitted diseases

Yes

No

Pharmaceutical Sector Country Profile Questionnaire.

Source

2007

WHO level I

2007

WHO level I

medicines 6.01.02.06

HIV/AIDS medicines

Yes

No

6.01.02.07

Expanded Program on Immunization (EPI) vaccines

Yes

No

6.01.02.08

If others, please specify

6.01.02.09

Please describe/explain your yes answers for questions above

6.01.03

Does a national health insurance, social insurance or other sickness fund provide at least partial medicines coverage?

Yes

No

6.01.03.01

Does it provide coverage for medicines that are on the EML for inpatients

Yes

No

6.01.03.02

Does it provide coverage for medicines that are on the EML for outpatients

Yes

No

6.01.03.03

Please describe the medicines benefit of public/social insurance schemes

6.01.04

Do private health insurance schemes provide any medicines coverage?

Yes

No

6.01.04.01

If yes, is it required to provide coverage for medicines that are on the EML?

Yes

No

6.01.05

Comments and References

Drug financing in Ethiopia, FMOH, 2007

2007

FMOH

Year

Source

2007

WHO level I

6.02 Patients Fees and Copayments Core Questions (click here for help)

6.02.01

In your health system, at the point of delivery, are there any copayment/fee requirements for

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 48

consultations 6.02.02

In your health system, at the point of delivery, are there any copayment/fee requirements for medicines

Yes

No

2007

WHO level I

6.02.03

In practice, (even though this may be contrary to regulations) is revenue from fees or sales of medicines sometimes used to pay the salaries or supplement the income of public health personnel in the same facility?

Yes

No

2007

WHO level I

6.02.03.01

Please describe the patient fees and copayments system

6.02.04

Comments and References

Year

Source

2007

WHO level I

2007

WHO level 1

6.02.02 Flat fees for medicines apply

6.03 Pricing Regulation for the Private Sector Core Questions (click here for help)

6.03.01

Are there legal or regulatory provisions affecting pricing of medicines

Yes

No

6.03.01.01

If yes, are the provisions aimed at Manufacturers

Yes

No

6.03.01.02

If yes, are the provisions aimed at Wholesalers

Yes

No

6.03.01.03

If yes, are the provisions aimed at Retailers

Yes

No

6.03.01.04

Please explain the positive answers above: (explain scope of provisions i.e generics vs. originator or subsets of medicines, EML etc.)

6.03.02

Government runs an active national medicines price monitoring system for retail prices

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 49

6.03.03

Regulations exists mandating that retail medicine price information should be publicly accessible

6.03.03.01

-if yes, please explain how the information is made publically available

6.03.04

Comments and References

Yes

No

2007

WHO level I

Year

Source

6.04 Prices, Availability and Affordability Core Questions (click here for help)

6.04.01-04

Please state if a medicines price survey using the WHO/HAI methodology has been conducted in the past 5 years in your country.

Yes

No

Unknown

If yes, please indicate the year of the survey and use the results to fill in this table If no, but other surveys on medicines prices and availability have been conducted, please do not use them to fill in this section, but rather use the comment box to write some of the results and attach the report to the questionnaire Public patient

Private patient

Orig

6.04.01.01

6.04.01.03

LPG

6.04.01.02

6.04.01.04

52.9

88

6.04.02.01

6.04.02.03

Basket Of key medicines Availability (one or both of)

Mean (%)

Median (%)

Public procurement

Orig

0

Pharmaceutical Sector Country Profile Questionnaire. 50

6.04.02.02

LPG

76.5

Price

Median Price Ratio

Orig

6.04.03.01

6.04.03.03

6.04.02.04

96

6.04.03.05 11.5

LPG

6.04.03.02

6.04.03.04

0.61

1.35

6.04.03.06

2.25

Affordability Days’ wages of the lowest paid govt worker for standard treatment

Number of days’ wages

6.04.04.01

Orig

7.9 LPG

with co-trimoxazole for a child respiratory infection

6.04.05

6.04.04.03

Comments and References

6.04.04.02

6.04.04.04

0.3

0.6

Source WHO/HAI Surveys of medicine pricing, availability and affordability

6.05 Price Components and Affordability Core Questions (click here for help) Year 6.05.01

Please state if a survey of medicines price components has been conducted in the past 5 years in your country

6.05.02

Median cumulative percentage markup between Manufacturer Selling Price (MSP)/ Cost Insurance and Freight (CIF) price and final medicine price for a basket of key medicines in the public sector (Median %

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 51

Unknown

Source

contribution) 6.05.03

Median cumulative percentage markup between MSP/CIF price and final medicine price for a basket of key medicines in the private sector (Median % contribution)

6.05.04

Comment and References

Supplementary questions (click here for help) 6.05.05S

Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the public sector (Median % contribution)

6.05.06S

Median percentage contribution of MSP/CIF to final medicine price for a basket of key medicines in the private sector (Median % contribution)

6.05.07S

Median manufacturer selling price (CIF) as percent of final medicine price for a basket of key medicines (%)

6.05.08S

Median wholesaler selling price as percent of final medicine price for a basket of key medicines (%)

6.05.09S

Median pharmacist mark-up or dispensing fee as percent of retail price for a basket of key medicines (%)

6.05.10S

Median percentage contribution of the wholesale mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)

6.05.11S

Median percentage contribution of the retail mark-up to final medicine price for a basket of key medicines (in the public and private sectors) (%)

Pharmaceutical Sector Country Profile Questionnaire. 52

6.05.12S

Comment and References

6.06 Duties and Taxes on Pharmaceuticals (Market) Core Questions (click here for help) Year

Source

6.06.01

There are duties on imported active pharmaceutical ingredients (APIs)

Yes

No

2007

WHO level I

6.06.02

There are duties on imported finished products

Yes

No

2007

WHO level I

6.06.03

VAT (value-added tax) or any other tax is levied on finished pharmaceuticals products

Yes

No

2010

Customs office

6.06.04

There are provisions for tax exceptions or waivers for pharmaceuticals and health products

Yes

No

2010

Cusetoms office

6.06.05

Please specify categories of pharmaceuticals on which the taxes are applied and describe the exemptions and waivers that exist

products such recin and pharmaceutical wastes are levied 15% VAT

6.06.06

Comments and References

VAT is levied only on some products such as pharmaceutical left overs.

Supplementary questions (click here for help) Year 6.06.07S

Duty on imported active pharmaceutical ingredients, APIs (%)

6.06.08S

Duty on imported finished products (%)

6.06.09S

VAT on pharmaceutical products (%)

6.06.10S

Comments and References

Pharmaceutical Sector Country Profile Questionnaire. 53

Source

Section 7 Pharmaceutical procurement and distribution 7.00 Respondent Information Section 6 7.00.01

Name of person responsible for filling out this section of the instrument

7.00.02

Phone number

7.00.03

Email address

7.00.04

Other respondents for filling out this section

7.01 Public Sector Procurement Core Questions (click here for help) Date 7.01.01

Public sector procurement is:

Yes

7.01.01.01

Decentralized

Yes

7.01.01.02

Centralized and decentralized

Yes

7.01.01.03

Please describe

7.01.02

If public sector procurement is wholly or partially centralized, it is under the responsibility of a procurement agency which

Yes

is: 7.01.02.01

Part of MoH

Yes

No

7.01.02.02

Semi-Autonomous

Yes

No

7.01.02.03

Autonomous

Yes

No

Pharmaceutical Sector Country Profile Questionnaire.

Source

7.01.02.04

A government procurement agency which procures all public goods

Yes

No

7.01.03

Public sector requests for tender documents are publicly available

Yes

No

7.01.04

Public sector tender awards are publicly available

Yes

No

7.01.05

Procurement is based on prequalification of suppliers

Yes

No

7.01.05.01

If yes, please describe how it works

7.01.06

Comments and References

http://sitersources.world bank.org

Supplementary questions (click here for help)

7.01.07S

Is there a written public sector procurement policy?. If yes, please write the year of approval in the "year" field

Yes

No

7.01.08S

Are there legal provisions giving priority in public procurement to goods produced by local manufacturers?

Yes

No

7.01.09S

The key functions of the procurement unit and those of the tender committee are clearly separated

Yes

No

7.01.10S

A process exists to ensure the quality of products procured

Yes

No

7.01.10.01S

If yes, the quality assurance process includes pre-qualification of products and suppliers

Yes

No

7.01.10.02S

If yes, explicit criteria and procedures exist for prequalification of suppliers

Yes

No

7.01.10.03S

If yes, a list of pre-qualified suppliers and products is publicly

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 55

Year

Source

2007

WHO level I

available 7.01.11S

List of samples tested during the procurement process and results of quality testing are available

7.01.12S

Which of the following tender methods are used in public sector procurement:

Yes

No

2007 Yes

7.01.12.01S

National competitive tenders

Yes

No

7.01.12.02S

International competitive tenders

Yes

No

7.01.12.03S

Direct purchasing

Yes

No

7.01.13S

Comments and References

WHO level I

7.02 Public Sector Distribution Core Questions (click here for help) Year 7.02.01

The government supply system department has a Central Medical Store at National Level

Yes

7.02.02

Number of public warehouses in the secondary tier of public distribution (State/Regional/Provincial)

8

7.02.03

There are national guidelines on Good Distribution Practices (GDP)

Yes

No

7.02.04

There is a licensing authority that issues GDP licenses

Yes

No

7.02.04.01

If a licensing authority exists, does it accredit public distribution facilities?

Yes

No

No

Pharmaceutical Sector Country Profile Questionnaire. 56

Source

2009

World bank

2009

World bank

7.02.05

List of GDP certified warehouses in the public sector exists

Yes

No

7.02.06

List of GDP certified distributors in the public sector exists

Yes

No

7.02.07

Comments and References

Ethiopia, Improving Health Systems, Public Sector Healthcare supply Chain Strategic Network Analysis and Design, 2009, The World Bank http://www.ghtechproject.com

Supplementary questions (click here for help) Year

7.02.08S

Which of the following processes is in place at the Central Medical Store:

Source

Yes

7.02.08.01S

Forecasting of order quantities

Yes

No

7.02.08.02S

Requisition/Stock orders

Yes

No

7.02.08.03S

Preparation of picking/packing slips

Yes

No

7.02.08.04S

Reports of stock on hand

Yes

No

7.02.08.05S

Reports of outstanding order lines

Yes

No

7.02.08.06S

Expiry dates management

Yes

No

7.02.08.07S

Batch tracking

Yes

No

7.02.08.08S

Reports of products out of stock

Yes

No

7.02.09S

Percentage % availability of key medicines at the Central Medical Store

73.3

7.02.10S

Average stock-out duration for a basket of medicines at the Central Medical Store, in days

61.1

7.02.11S

Routine Procedure exists to track the expiry dates of medicines at the Central Medical Store

Yes

2010

No

Pharmaceutical Sector Country Profile Questionnaire. 57

WHO Level II Survey

7.02.12S

The Public Central Medical Store is GDP certified by a licensing authority

Yes

No

7.02.13S

The Public Central Medical Store is ISO certified

Yes

No

7.02.14S

The second tier public warehouses are GDP certified by a licensing authority

Yes

No

7.02.15S

The second tier public warehouses are ISO certified

Yes

No

7.02.16S

Comments and References

WHO Level II survey 2010 data that is not yet made public.

7.03 Private Sector Distribution Core Questions (click here for help)

7.03.01

Legal provisions exist for licensing wholesalers in the private sector

Yes

No

Year

Source

2010

Procl. 661/2009 FDRE

7.03.02

Legal provisions exist for licensing distributors in the private sector

Yes

No

2010

Procl. 661/2009 FDRE

7.03.03

List of GDP certified wholesalers in the private sector exists

Yes

No

7.03.04

List of GDP certified distributors in the private sector exists

Yes

No

7.03.05

Comments and References

Proclamation No 661/2009, FMOH, Ethiopia directive for issuance of certificate of compitence for importers and wholesalers.

Pharmaceutical Sector Country Profile Questionnaire. 58

Section 8 Selection and rational use 8.00 Respondent Information Section 7 8.00.01

Name of person responsible for filling out this section of the instrument

8.00.02

Phone number

8.00.03

Email address

8.00.04

Other respondents for filling out this section

8.01 National Structures Core Questions (click here for help) Year 8.01.01

8.01.01.01

National essential medicines list (EML) exists. If yes, please write year of last update of EML in the "year" field

If yes, number of medicines on the EML (no. of INN)

Yes

No

Source

2010 DACA

345

8.01.01.02

If yes, there is a written process for selecting medicines on the EML

Yes

No

8.01.01.03

If yes, the EML is publicly available

Yes

No

8.01.01.04

If yes, is there any mechanism in place to align the EML with the Standard Treatment Guidelines (STG)

Yes

No

8.01.02

National Standard Treatment Guidelines (STGs) for most common illnesses are produced/endorsed by the MoH. If yes, please insert year of last

Yes

No

Pharmaceutical Sector Country Profile Questionnaire.

2010 DACA

update of STGs in the "year" field 8.01.03

8.01.04

8.01.05

8.01.06

STGs specific to Primary care exist. Please use the "year" field to write the year of last update of primary care guidelines

Yes

STGs specific to Secondary care (hospitals) exists. Please use the "year" field to write the year of last update of secondary care STGs.

Yes

STGs specific to Paediatric conditions exist. Please use the "year" field to write the year of last update of paediatric condition STGs

Yes

% of public health facilities with copy of EML (mean)- Survey data

8.3

No

2010 DACA

No

2010 DACA

No

2010 DACA

2010

WHO level I

8.01.07

% of public health facilities with copy of STGs (mean)- Survey data

2010 19.4

WHO

level I 8.01.08

A public or independently funded national medicines information centre provides information on medicines to prescribers, dispensers and consumers

Yes

No

8.01.09

Public education campaigns on rational medicine use topics have been conducted in the previous two years

Yes

No

8.01.10

A survey on rational medicine use has been conducted in the previous two years

Yes

No

2007

Pharmaceutical Sector Country Profile Questionnaire. 60

WHO level I

8.01.11

A national programme or committee (involving government, civil society, and professional bodies) exists to monitor and promote rational use of medicines

Yes

No

2007

WHO level I

8.01.12

A written National strategy exists to contain antimicrobial resistance. If yes, please write year of last update of the strategy in the "year" field

Yes

No

2007

WHO level I

8.01.13

Comments and References

Year

Source

2010

DACA

2007

WHO level I

WHO level I

Supplementary questions (click here for help)

8.01.14S

The Essential Medicines List (EML) includes formulations specific for children

Yes

No

8.01.15S

There are explicitly documented criteria for the selection of medicines in the EML

Yes

No

8.01.16S

There is a formal committee or other equivalent structure for the selection of products on the National EML

Yes

No

8.01.16.01S

If yes, conflict of interest declarations are required from members of national EML committee

Yes

No

8.01.17S

National medicines formulary exists

Yes

No

2007

8.01.18S

Is there a funded national intersectoral task force to coordinate the promotion of appropriate use of antimicrobials and prevention of spread of infection?

Yes

No

2007

8.01.19S

A national reference laboratory/or any other institution has responsibility for coordinating

Yes

No

2007

Pharmaceutical Sector Country Profile Questionnaire. 61

WHO level I

epidemiological surveillance of antimicrobial resistance 8.01.20S

Comments and References

8.02 Prescribing Core Questions (click here for help) Year 8.02.01

Legal provisions exist to govern the licensing and prescribing practices of prescriber

Yes

No

Source

2010 Proc.

661/2009 8.02.02

Legal provisions exist to restrict dispensing by prescribers

Yes

No

2010

Proc. 661/2009

8.02.03

Do prescribers in the private sector dispense medicines?

Yes

No

2010

Proc. 661/2009

8.02.04

Regulations require hospitals to organize/develop Drug and Therapeutics Committees (DTCs)

Yes

No

8.02.05

Do more than half of referral hospitals have a DTC?

Yes

No

Unknown

8.02.06

Do more than half of general hospitals have a DTC?

Yes

No

Unknown

2007

WHO level I

8.02.07

Do more than half of regions/provinces have a DTC?

Yes

No

Unknown

2007

WHO level I

8.02.08

The core medical training curriculum includes components on:

2007

WHO level I

2007

Yes

8.02.08.01

Concept of EML

Yes

No

8.02.08.02

Use of STGs

Yes

No

8.02.08.03

Pharmacovigilance

Yes

No

Pharmaceutical Sector Country Profile Questionnaire. 62

2007

WHO level I

WHO level I

8.02.08.04

Problem based pharmacotherapy

Yes

No

8.02.09

Mandatory continuing education that includes pharmaceutical issues is required for doctors (see physician)

Yes

No

8.02.10

Mandatory continuing education that includes pharmaceutical issues is required for nurses

Yes

No

8.02.11

Mandatory continuing education that includes pharmaceutical issues is required for paramedical staff

Yes

No

8.02.12

Prescribing by INN name is obligatory in:

2007

WHO level I

2007

WHO level I

2007

WHO level I

Yes

8.02.12.01

Public sector

Yes

No

8.02.12.02

Private sector

Yes

No

8.02.13

Average number of medicines prescribed per patient contact in public health facilities (mean)

2010 WHO

2.01

level II 8.02.14

% of medicines prescribed in outpatient public health care facilities that are in the national EML (mean)

2010 WHO

98.3

level II 8.02.15

% of medicines in outpatient public health care facilities that are prescribed by INN name (mean)

8.02.16

% of patients in outpatient public health care facilities receiving antibiotics (mean)

87.9

2010

WHO level II

2010 WHO

60.0

level II

Pharmaceutical Sector Country Profile Questionnaire. 63

8.02.17

% of patients in outpatient public health care facilities receiving injections (mean)

2010 WHO

23.3

level II 8.02.18

% of prescribed drugs dispensed to patients (mean)

8.02.19

% of medicines adequately labeled in public health facilities (mean)

86.0

2010

WHO level II

2010 WHO

87.0

level II 8.02.20

Comments and References

8.02.05 - 8.02.07 a FEW - exact proportion unknown

Supplementary questions (click here for help) Year 8.02.21S

A professional association code of conduct exists governing professional behaviour of doctors

Yes

No

8.02.22S

A professional association code of conduct exists governing professional behaviour of nurses

Yes

No

8.02.23S

Diarrhoea in children treated with Oral Rehydration Solution (ORS) (%)

70.9

8.02.24S

Comments and References

http://www.ema.org.et

Source

2010

EMA

2010

WHO level II

http://www.ena.org.et

8.03 Dispensing Core Questions (click here for help) Year 8.03.01

Legal provisions exist to govern dispensing practices of pharmaceutical personnel

Yes

No

2010

Pharmaceutical Sector Country Profile Questionnaire. 64

Source

Proc. 661/2009

8.03.02

The basic pharmacist training curriculum includes components on:

2007

WHO level I

Yes

8.03.02.01

Concept of EML

Yes

No

8.03.02.02

Use of STGs

Yes

No

8.03.02.03

Drug Information

Yes

No

8.03.02.04

Clinical pharmacology

Yes

No

8.03.02.05

Medicines supply management

Yes

No

8.03.03

Mandatory continuing education that includes rational use of medicines is required for pharmacists

Yes

No

2007

WHO level I

8.03.04

Generic substitution at the point of dispensing in public sector facilities is allowed

Yes

No

2007

WHO level I

8.03.05

Generic substitution at the point of dispensing in private sector facilities is allowed

Yes

No

2007

WHO level I

8.03.06

In practice, (even though this may be contrary to regulations) are antibiotics sometimes sold overthe-counter without any prescription?

Yes

No

Unknown

2007

WHO level I

8.03.07

In practice, (even though this may be contrary to regulations) are injections sometimes sold over-thecounter without any prescription?

Yes

No

Unknown

2007

WHO level I

8.03.08

Comments and References

http://www.epaethiopia.org

Supplementary questions (click here for help) Year 8.03.09S

A professional association code of conduct exists governing professional behaviour of

Yes

No

2006

Pharmaceutical Sector Country Profile Questionnaire. 65

Source

EPA

pharmacists 8.03.10S

In practice, (even though this may be contrary to regulations) do the following groups of staff sometimes prescribe prescription-only medicines at the primary care level in the public sector?

2007 Yes

8.03.10.01S

Nurses

Yes

No

Unknown

8.03.10.02S

Pharmacists

Yes

No

Unknown

8.03.10.03S

Paramedics

Yes

No

Unknown

8.03.10.04S

Personnel with less than one month training

Yes

No

Unknown

8.03.11S

Comments and References

Standard treatment guideling for health centers, FMOH

Pharmaceutical Sector Country Profile Questionnaire. 66

WHO level I

Section 9 Household data/access 9.00 Respondent Information section 8 9.00.01

Name of person responsible for filling out this section of the instrument

9.00.02

Phone number

9.00.03

Email address

9.00.04

Other respondents for filling out this section

9.01 Data from Household Surveys Core Questions (click here for help) Year

Source

9.01.01

What household surveys have been undertaken in the past 5 years to assess access to medicines?

9.01.02

Adults with acute condition in twoweek recall period who took all medicines prescribed by an authorized prescriber (%)

85.1

2003

WHS

9.01.03

Adults with acute conditions not taking all medicines because they cannot afford them (%)

27.8

2003

WHS

9.01.04

Adults (from poor households) with an acute health condition in twoweek recall period who took all medicines prescribed by an authorized prescriber (%)

92.6

2003

WHS

9.01.05

Adults (from poor households) with an acute condition in two-week recall period who did not take all medicines because they cannot afford them (%)

20.9

2003

WHS

Pharmaceutical Sector Country Profile Questionnaire.

9.01.06

Adults with chronic conditions taking all medicines prescribed by an authorized prescriber (%)

77.5

2003

WHS

9.01.07

Adults (from poor households) with chronic conditions not taking all medicines because they cannot afford them (%)

90.4

2003

WHS

9.01.08

Adults (from poor households) with chronic conditions who usually take all medicines prescribed by an authorized prescriber (%)

77.1

2003

WHS

9.01.09

Children (from poor households) with an acute condition in two-week recall period who took all medicines prescribed by an authorized prescriber (%)

91.9

2003

WHS

9.01.10

Percentage of people that obtained the medicines prescribed in the 15 days before the interview (%)

9.01.11

People that obtained prescribed medicines for free in the 15 days before the interview (%)

9.01.12

Comments and References

Supplementary questions (click here for help) Year

Source

9.01.13S

Adults with acute conditions not taking all medicines because the medicines were not available (%)

63.3

2003

WHS

9.01.14S

Adults with chronic conditions not taking all medicines because they cannot afford them (%)

58.9

2003

WHS

9.01.15S

Adults with chronic conditions not taking all medicines because the medicines were not available (%)

38.3

2003

WHS

9.01.16S

Children with acute conditions taking all medicines prescribed by

85.9

2003

WHS

Pharmaceutical Sector Country Profile Questionnaire. 68

an authorized prescriber (%) 9.01.17S

Children with acute conditions not taking all medicines because they cannot afford them (%)

42.2

2003

WHS

9.01.18S

Children with acute conditions not taking all medicines because the medicines were not available (%)

50.2

2003

WHS

9.01.19S

Children (from poor households) with acute conditions not taking all medicines because they cannot afford them (%)

26.9

2003

WHS

9.01.20S

Comments and References

Pharmaceutical Sector Country Profile Questionnaire. 69

Glossary

Key Documents to be attached

Document

Exact title

Author

National Medicines Policy (NMP) NMP implementation plan National Medicines Act National pharmaceutical human resources report or strategic plan Latest report on the national pharmaceutical market (any source) National Pharmacovigilance Centre report (including Adverse Drug Reaction, ADR, analysis report in the last two years) National pharmaceutical legislation for regulation Annual report of quality control laboratories Annual report of national regulatory authority Legal provisions on medicines price regulations Medicines procurement policy National Essential Medicines List (EML) National Standard Treatment Guidelines (STGs) National Strategy for antimicrobial resistance Pharmaceutical Sector Country Profile Questionnaire. 70

Publisher

Year

File name

Glossary Any other medicines pricing/availability surveys, household surveys, and rational use surveys than the ones used to prefill in the instrument.

Pharmaceutical Sector Country Profile Questionnaire. 71

Glossary

Pharmaceutical Sector Country Profile Questionnaire. 72